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Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE)

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No

Objective

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd.

The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

Details

Full study title A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections
Protocol number OCR43328
ClinicalTrials.gov ID NCT05605093
Phase Phase 3

Eligibility

Inclusion Criteria:

  • Age ≥18 years.

  • Informed consent for trial participation.

  • Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection.

  • Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test [list of approved tests is in the PIM] collected within the prior 14 days.

  • Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization.

  • Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection.

Exclusion Criteria:

  • The patient is expected to be discharged from the hospital within the next 24 hours.

  • Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization.

  • Use of a strong CYP3A inducer within 14 days prior to enrollment

  • Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization.

  • Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.

  • Expected inability or unwillingness to participate in study procedures.

  • In the opinion of the investigator, participation in a trial is not in the best interest of the patient.

  • Allergy to investigational agent or vehicle

  • Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622

  • Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure.

  • Known estimated glomerular filtration rate (eGRF)

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.